Advertisement

Design Parameters for Drug-Coated Balloons II

  • Manish Doshi
  • Dinesh Shah
  • Prakash SojitraEmail author
Chapter

Abstract

The drug-coated balloon (DCB) is an emerging device since the focus on the bioabsorbable stent has shifted due to its mixed results. Currently paclitaxel and sirolimus are two choices in DCBs and both drugs have their own advantages. Use of sirolimus on DCBs is not yet well known but may replace use of of paclitaxel in the coming years when key design criteria are compared. From the scientific perspective, researchers developing DCB in the laboratory need to consider certain criteria. DCB development needs to fulfill multiple criteria with regard to the drug, device, drug carrier, physicochemical properties of the drug and drug carrier, particle size and coating methodology.

Keywords

Drug-coated balloon Sirolimus Paclitaxel 

References

  1. 1.
    Norgren L, Hiatt WR, Dormandy JA, et al. TASC II Working Group inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–S67.CrossRefGoogle Scholar
  2. 2.
    European Stroke Organisation, Tendera M, Aboyans V, ESC Committee for Practice Guidelines, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–906.CrossRefGoogle Scholar
  3. 3.
    Chalmers N, Walker PT, Belli AM, et al. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol. 2013;36(2):353–61.CrossRefGoogle Scholar
  4. 4.
    Loh JP, Barbash IM, Waksman R. The current status of drug-coated balloons in percutaneous coronary and peripheral interventions. EuroIntervention. 2013;9(8):979–88.CrossRefGoogle Scholar
  5. 5.
    Zeller T, Schmitmeier S, Tepe G, et al. Drug-coated balloons in the lower limb. J Cardiovasc Surg. 2011;52(2):235–43.Google Scholar
  6. 6.
    Scheller B. The Invatec IN-PACT Falcon paclitaxel DEB: device description and clinical studies. In: Transcatheter Cardiovascular Therapeutics, Washington, DC, 21–25 Sep 2010.Google Scholar
  7. 7.
    Abal M, Andreu JM, Barasoain I. Taxanes: microtubule and centrosome targets, and cell cycle dependent mechanisms of action. Curr Cancer Drug Targets. 2003;3:193–203.CrossRefGoogle Scholar
  8. 8.
    Wang TH, Wang HS, Soong YK. Paclitaxel-induced cell death: where the cell cycle and apoptosis come together. Cancer. 2000;88:2619–28.CrossRefGoogle Scholar
  9. 9.
    Poon M, Marx SO, Gallo R, et al. Rapamycin inhibits vascular smooth muscle cell migration. J Clin Invest. 1996;98:2277–83.CrossRefGoogle Scholar
  10. 10.
    Marks AR. Sirolimus for the prevention of in-stent restenosis in a coronary artery. N Engl J Med. 2003;349:1307–9.CrossRefGoogle Scholar
  11. 11.
    Hwang C-W, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation. 2001;104:600–5.CrossRefGoogle Scholar
  12. 12.
    Schwartz SM. Smooth muscle migration in atherosclerosis and restenosis. J Clin Invest. 1997;100:S87–9.PubMedGoogle Scholar
  13. 13.
    Levin AD, Vukmirovic N, Hwang C-W, et al. Specific binding to intracellular proteins determines arterial transport properties for rapamycin and paclitaxel. Proc Natl Acad Sci U S A. 2004;101:9463–7.CrossRefGoogle Scholar
  14. 14.
    Gervasoni JE Jr, Hindenburg AA, Vezeridis MP, et al. An effective in vitro antitumor response against human pancreatic carcinoma with paclitaxel and daunorubicin by induction of both necrosis and apoptosis. Anticancer Res. 2004;24:2617–26.PubMedGoogle Scholar
  15. 15.
    Creel CJ, Lovich MA, Edelman ER. Arterial paclitaxel distribution and deposition. Circ Res. 2000;86:879–84.CrossRefGoogle Scholar
  16. 16.
    Yang C, Burt HM. Drug-eluting stents: factors governing local pharmacokinetics. Adv Drug Deliv Rev. 2006;58:402–11.CrossRefGoogle Scholar
  17. 17.
    Bozsak F, Gonzalez-Rodriguez D, Sternberger Z, Belitz P, Bewley T, Chomaz J-M. Optimization of drug delivery by drug-eluting stents. PLoS One. 2015;10(6):e0130182.CrossRefGoogle Scholar
  18. 18.
    Revolvy. Butyryl trihexyl citrate topics. https://www.revolvy.com/main/index.php?s=Butyryl%20trihexyl%20citrate&stype=topics&cmd=list. Accessed 7 Dec 2017.
  19. 19.
    Lemos Neto PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, et al. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013;9(1):146–56.  https://doi.org/10.4244/EIJV9I1A21.CrossRefGoogle Scholar
  20. 20.
    Takimura CK, Galon MZ, Sojitra P, Doshi M, et al. Excipient:drug dose determination for neointimal hyperplasia as assessed by optical coherence tomography and histopathology in porcine coronary arteries after sirolimus-eluting balloon deployment. Rev Bras Cardiol Invasiva. 2012;20(2):133–9.Google Scholar
  21. 21.
    Cortese B, di Palma G, Latini RA, Elwany M, Orrego PS, Seregni RG. Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The Fatebenefratelli Sirolimus Coated-Balloon (FASICO) registry. Cardiovasc Revasc Med. 2017;18(7):487–91.CrossRefGoogle Scholar
  22. 22.
    Granada JF, et al. In vivo delivery and long-term tissue retention of nano-encapsulated sirolimus using a novel porous balloon angioplasty system. EuroIntervention. 2016;12:740–7.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Concept Medical Research Private LimitedSuratIndia
  2. 2.William Beaumont HospitalRoyal OakUSA

Personalised recommendations